Apparatus for providing proper vertebral spacing

ABSTRACT

An expandable osteosynthesis implant has branches ( 5 ) each connected at one end to a seat ( 7 ) which is pierced by an orifice ( 8 ), suitable for being slid from a posterior direction between the facing faces of two consecutive vertebrae in order to hold them a given distance apart and restore stability of the spinal column. According to the invention, said branches ( 5 ) and said seat ( 7 ) define a hollow cage ( 1 ) which, in a “rest” position, has an outside general shape that is a cylinder of circular section, and a portion at least of the inside volume ( 9 ) of the cage ( 1 ) towards the distal ends of said branches ( 5 ) is in the form of a circular truncated cone whose large base is towards said seat ( 7 ), which implant has at least three branches ( 5 ) and, inside said inside volume ( 9 ) at least one spacer ( 2 ) suitable for passing through said orifice ( 8 ) and the large base of the truncated cone.

The present invention relates to an expandable osteosynthesis cage.

The technical field of the invention is that of implantable boneimplants or prostheses and the surgical techniques for using them.

The main application of the invention is to provide implants designed tobe slid or inserted from a posterior direction between the facing facesof two consecutive vertebrae in order to maintain a given distancebetween them and to restore the stability of the spinal column, e.g.after a failure of the corresponding joint, by fixing the two vertebraetogether.

Several techniques are known at present for restoring a “normal” lumbarlordosis in this way, by implanting either a graft which in time fusesthe vertebrae together, or a prosthesis which fixes them togetherimmediately, while still also making it possible in time to achievefusion between the vertebra.

In the second above-mentioned technique, use is made mainly of implants,also known as “cages”, some of which are hollow, rigid, and one-piece,with inside/outside intercommunication slots for receiving a bone graftwhich, via said slots, subsequently fuses with the adjacent vertebrae oneither side: in this field, reference can be made to patent applicationWO 96/08205 published on Mar. 21, 1996 for a “Intervertebral fusion cageof conical shape” and application EP 637 440 published on Feb. 8, 1995for an “Intersomatic implant for the spinal column”. Nevertheless, cagesof those types are of outside dimensions that are given and fixed,whereas the distances between pairs of vertebrae are not constant. Inaddition, the inclinations of the facing vertebral aces to which a givenangular position is to be imparted do not enable rigid cages to be usedfrom a posterior direction: they can be inserted only from an anteriordirection.

As a result, other types of cage have been developed with twosubstantially parallel branches connected to a rigid body through whichit is possible to turn a wormscrew system which then moves a wedge inscrew engagement on said screw from an initial position close to thedistal ends of the branches towards the body linking the branchestogether, thereby splaying the two branches apart angularly. It is thenpossible to insert such a cage of initially flat shape between thevertebrae, and then by turning the drive axis of the wedge, the desiredangle between the branches is adjusted or set from a posterior access.

Such cages or implants are described, for example, in European patentapplication EP 664 994 published on Aug. 2, 1995, entitled “Vertebralintersomatic cage” or in application EP 2 719 763 published on Nov. 17,1995, and entitled “Vertebral implant”.

Nevertheless, such devices which are more mechanical than hollow andrigid cages, and therefore more complex, leave a smaller inside volumefor the fusion graft, and because of their flat shape which is notcircularly symmetrical, even though they are better at ensuring a givenbearing angle between the vertebrae, they require a passage of the samerectangular section to be prepared to receive them, and that complicatesimplementation.

The problem posed is thus to be able to have implants or cages availablemaking it possible simultaneously to ally the shape of a conventionalrigid cage, firstly to facilitate implantation and secondly to provide alarger inside volume, with the possibility of increasing the diameter ofthe distal end of the cage to a given value relative to its end situatedadjacent to its point of surgical insertion, after it has been put intoplace, and corresponding to the posterior race of the vertebrae, whilehaving as few mechanical elements as possible.

A solution to the problem posed is an expandable osteosynthesis implanthaving branches each connected at one end to a seat pierced by anorifice, such that said branches and the seat constitute a hollow cagewhich, in a “rest” position, has an outside general shape that iscylindrical or quasi-cylindrical with the generator line that generatesit by rotating about its axis of symmetry being either a straight lineor having a curved middle portion such as a convex circular arc of largeradius, and having a director curve around which the generator linetravels, thus also defining the cross-section of the cylinder, which isquasi-circular: this provides a cylinder that is either a right circularcylinder or else a cylinder that is referred to in the present case asbeing “ovoid” or “oval”, and which is referred to below as being acylinder or a quasi-cylinder; a portion at least of the inside volume ofthe cage towards the distal ends of the branches is in the form of aquasi-circular truncated cone whose large base is towards said seat,said implant having at least three branches and at least one spacer ofdimensions compatible with the dimensions of the large base of thetruncated cone in said inside volume in the rest position, and possiblysuitable for passing through said orifice.

In an “active” position, said spacer splays said branches apart, saidinside volume tends towards a circular cylinder, and the outside shapeof the cage tends towards an approximate truncated cone, and once thespacer has been put into the desired position, no internal part remainsinside the space defined by said branches, the spacer, and the orifice.

The definitions of the “rest” and “active” positions are shown by way ofexample respectively in FIGS. 1, 3A, 4A, 5A, 9, 10, and 11, and in FIGS.2, 3B, 3C, 4B, and 5B. The “rest” position is the position of theimplant before it is put into place and while it is being put intoplace, i.e. without the spacer positioned between its branches insidethe cage, so the cage has a cylindrical outside volume of constantsection. The “active” position is the final position of the implant,e.g. between two vertebrae, with its branches splayed apart by thespacer being placed in its final adjustment position, the generaloutside shape of the cage then being approximately frustoconical,flaring away from the seat, which corresponds to the end of the implantsituated towards its point of surgical insertion, towards its distal endwhich is placed in deeper between the vertebrae.

To provide better anchoring in the bone and to avoid any subsequentmigration of the cage, the outside surfaces of said branches arepreferably either knurled, is grooved, or threaded using a threadprofile having projecting ridges, etc.

Also, to reduce any risk of rotation after implantation, and thus reduceany risk of displacement of the cage, while simultaneously increasingcontact area with the faces of the vertebrae, at least the seat of theimplant and preferably also the sides of the branches have at least twooptionally parallel flats, each disposed symmetrically about the axis ofthe implants between two successive branches. These flats, optionallyassisted by the generally ovoid shape of the cage, make better retentionpossible after expansion by reducing any risk of the implant rotating.In addition, said ovoid shape can make it possible, better than if theouter generator line of the basic cylindrical shape of the cage at restwere a straight line, to return after expansion to an outside profilethat is conical and without curvature, thereby providingbetter-distributed thrust against the body of the vertebrae, thushelping the bone graft to take better.

To stiffen the cage at its posterior end, particularly if there is alarge oriface in the seat, thereby making it easier to fill the cagewith bone matter after the cage has been put into place and expanded,the orifice of said seat is suitable for receiving a plug for closingthe inside volume of the cage. By way of example, the plug can bescrewed into said orifice, in which case the orifice is also threaded.Under such circumstances, the plug prevents bone matter from escapingand depending on the material out of which it is made, it can alsostiffen the cage.

Various particular embodiments are described below in the accompanyingfigures. The result is novel expandable osteosynthesis implantssatisfying the problem posed, in particular for the above-defined mainapplication.

The presence of at least four branches, and possibly four to eightbranches, makes it possible to obtain bilateral expansion, and therebybetter jamming against. the two facing faces of the vertebrae, and theabsence of a link part or rod between the spacer maintaining saidexpansion and the orifice or plug in the end seat guarantees a largerinside volume for receiving a large quantity of bone matter, therebyimproving consolidation and joining by fusion, in particular between thevertebrae that are to be held together. Said filling operation is madethat much easier by having a large orifice at the posterior end of thecage through said seat.

In addition, said orifice makes it possible to scrape the faces of thevertebrae through the slots situated between the branches in the bottomand top faces of the cage.

Furthermore, the expansion system as defined above is very simple, sinceit comprises only two parts, namely the spacer and the cage (optionallyhaving a plug situated at its end and possibly also having anintermediate spacer, as mentioned -below) but no link member remainingafter installation, since any rod or shaft for positioning said spacersand said plug is subsequently removed.

The present invention thus provides numerous advantages over existingimplants or cages, of the kind already mentioned, and other advantagescan also be provided but those given above suffice to demonstrate thenovelty and the usefulness of the invention.

The description and the figures below show two embodiments of theinvention with four branches, but they are not limiting in any way:other embodiments are possible in the context of the ambit of the scopeof this invention, for example embodiments with three branches orembodiments with more than four.

FIG. 1 is a perspective view of an example of an implant in the “rest”position with its various parts in alignment on a common installationaxis XX′.

FIG. 2 is a perspective view of the FIG. 1 implant in its “active”position with the above three parts assembled together.

FIGS. 3A, 4A, and 5A are respectively a section view, and two axial endviews, one of the anterior face and the other of the posterior face of acage showing another embodiment of an implant of the invention in the“rest” position.

FIGS. 3B, 4B, and 5B show the same views as are shown in FIGS. 3A, 4A,and 5A, of the same cage, but with its complementary elements assembledtogether into the “active” position.

FIG. 3C is a side view perpendicular to the axis of the implant of theembodiment shown in FIGS. 3, 4, and 5, in the “active” position.

FIGS. 6, 7, and 8 are figures showing embodiment details of the cage ofthe implant of the invention.

FIGS. 9, 10, and 11 are respectively a fragmentary side view, and twoaxial views showing the anterior face and the posterior face of theembodiment of the implant shown in perspective in FIGS. 1 and 2.

FIGS. 12, 13, and 14 are a face view and a section view respectively of:a non-screw end spacer for the embodiment of FIGS. 1, 2, 9, 10, and 11;a screw end and/or intermediate spacer for an embodiment of FIGS. 3, 4,and 5, and a closure plug for any of the embodiments of the invention.

Whatever the embodiment, the expandable osteosynthesis implant comprisesin conventional manner branches 5, each connected at one end to a seat 7pierced by an orifice 8. According to an essential characteristic of theinvention, said branches 5 and the seat 7 constitutes a hollow cage 1which, in a “rest” position as shown for the embodiments of FIGS. 1, 3A,4A, and 5A, and of FIGS. 9, 10, and 11, is of general outside shape thatis cylindrical or quasi-cylindrical having a cross-section which is alsothe director curve of said cylinder that is circular or quasi-circular,with the generator line which engages said director curve and whichgenerates the cylinder or quasi-cylinder by moving around its axis ofsymmetry XX′ being either a straight line or a convex circular arc oflarge radius: this provides either a circularly-symmetrical rightcylinder as shown in solid lines 20 ₁ in FIG. 3A, or else apseudo-cylinder referred to in the present specification as being “oval”or “ovoid”, i.e. being of slightly bulging outside shape, as shown inlong and short dashed lines 202 in FIG. 3A. At least a portion of theinside volume 9 of the cage 1 towards the distal ends of the branches 5is in the form of a truncated cone that is quasi-circularly symmetricalwith its larger base being closer to said seat 7, which implant has atleast four branches 5 and at least one spacer 2 suitable for passingthrough said orifice 8 and via the large base of the truncated cone intosaid inside volume 9

In FIGS. 2, 3B, 4B, 5B, and 3C, i.e. in the “active” position, said endspacer 2 spreads apart said branches 5, said inside volume 9 thentending towards a circular cylinder while the outside shape of the cage1 tends towards an approximate truncated cone. In FIG. 3B, for example,solid lines 20 ₁ show the slightly concave shape obtained from a regularbase cylinder in the rest position while short and long dashed lines 20₂ shows the straighter shape obtained from a cylinder that was initiallyovoid, as shown in FIG. 3A. Once the spacer 2 has been placed in thedesired position, no internal part that has been used for putting theimplant and the spacers in place remains inside the space defined bysaid branches 5, the spacer 2, and the orifice 8.

Whatever the embodiment, at least a portion of the outside surface ofsaid branches 5 is threaded with a thread profile 11 having projectingridges, as shown in detail in FIG. 7. In particular, by way of example,for a cage having a length L of about 20 mm to 25 mm, the length l ofthe threaded portion of the branches 5 may lie in the range 13 mm to 16mm with a pitch p of 1.5 mm to 2 mm, the outside diameter D of thecircular cylinder of the cage being 9 mm to 16 mm and the height of atooth 11 ₁ of the thread being of the order of 0.7 mm to 0.9 mm for athread angle β between successive teeth being about 60°, and with aninside profile 11 ₂ of the thread having a radius of about 0.4 mm. Saidrounded shape of the profile minimizes stress concentrations, thusmaking it possible to withstand large forces and impacts.

Such an outside thread with projecting ridges thus facilitatesinstallation since it is not traumatizing, given that there is no impactshock while inserting said implant since it is screwed into a holepreviously bored by any tool compatible with the orifice 8 of theimplant, and once in place such a thread also provides anchoring in thebone, thereby avoiding any subsequent migration.

The seat 7 may include at least two flats 6 that are parallel orslightly inclined relative to each other to fit the profile of vertebraemore closely, each disposed between two successive branches 5 as shownin the embodiments of FIGS. 1, 2, 9, 10, and 11. Alternatively, the seat7 may have four flats forming a square or pseudo-square section, asshown in the embodiment of FIGS. 3, 4, and 5. In addition to the seat,the branches 5 themselves may also have respective flats at least inline with those of the seat, as shown in the embodiment of FIGS. 3 to 5,particularly if the section of the implant is quasi-circular, oralternatively may have no flats at all, as in the embodiment of FIGS. 1,2 and 9 to 11. Such flats may be replaced or at least associated with alongitudinal implant section that is slightly oval or ovoid in shape, asmentioned above.

The orifice 8 of the seat 7 can be threaded with a thread profile 15 asshown by way of example in FIG. 6, with a thread pitch that is roundedboth at its ridges and in its furrows, and for association with thedimensions given above by way of example, an opening 8 may have aninside diameter d of 7 mm to 10 mm, a pitch p′ of 1 mm to 1.5 mm, athread depth of about 0.6 mm, and a thread angle γ between the walls ofthe thread of about 30°.

A plug 3 for closing the inside volume 9 is then screwed into saidorifice 8, either to serve as an anchor point for an implant-installingrod, or else after the implant has been put into place and the brancheshave been splayed apart by the end spacer 2 for the purpose of closingthe inside volume 9 in order firstly to stiffen the cage and secondly toprevent any bone matter that may have been implanted inside the cagefrom escaping via said posterior end.

Such a plug 3 is shown in face view in FIG. 14A and in side view in FIG.14B, having a thread 152 of the type shown in FIG. 6 and a centralorifice 17 of polygonal shape, being square, hexagonal, etc., orreplaced by any means suitable for securing therein the end of a rodhaving a compatible end for the purpose of enabling the plug to bescrewed and unscrewed.

In addition, it is possible to form on the posterior face of the implantand at the periphery of the orifice 8 in the seat 7, studs or groovesserving to secure a portion of the “ancillary” installation appliancearound the rod, enabling the cage 1, spacers, and/or the plug 3 to bedriven so as to fix more securely the positioning of the implant whileit is being put into place and so as to facilitate dismantling of theancillary appliance without moving the implant.

In the embodiments shown with four branches 5, said cage 1 has fourslots 10 forming inter-branch spaces as shown in FIG. 8 looking alongarrow VIII of FIG. 9, for example Such slots serve firstly to improvefusion of the bone graft that may be housed in the inside volume 9 withthe adjacent intervertebral disks, and secondly to obtain betterdeformation of the branches 5 during. installation of the implant, thebranches in this particular portion being of section that is smallerthan at their ends. In addition, such slots can be oblong in shape withtheir ends situated towards the distal ends of the branches 5 beingnarrower than their opposite ends, as shown in FIG. 8, and terminatingin a narrow slit 10 ₁ between the distal ends of adjacent pairs of saidbranches. Such a shape, at least for the main slot 10, makes it possibleto have a slot with parallel edges, once the cage has been expanded. Inaddition, choosing a profile of this shape instead of an initial slot ofconstant width as shown in FIG. 3A, makes it possible to increase thebearing surface area between the spacer 2 and the distal ends of thebranches 5 of the cage, thus providing greater strength.

In the embodiments of FIGS. 1, 2, 9, 10, and 11, the inside surfaces ofthe branches 5 defining the inside volume 9 of the cage 1 are smooth, sothe volume then includes at its distal end an axial housing 12 suitablefor receiving said spacer 22 as shown in FIG. 12, and for holding it bymeans of a shoulder 13 of greater diameter than that of the insidevolume 9 of the cage in its active position, as shown in FIG. 1.

Said spacer 22 has a threaded axial bore 14 suitable for receiving a rodwhose end at least is likewise threaded and compatible for the purposeof putting the spacer into place merely by applying thrust and by beingmoved in translation, with said installation rod being subsequentlyremovable.

In FIGS. 1 and 2, in order to avoid any risk of the body of the cage 1deforming at its anterior end near the distal ends of the branches 5under large stresses due to pressure from adjacent vertebrae, whichcould have the effect of moving branches towards one another by slidingaround the spacer 2, it is possible to provide the spacer with at leasttwo splines 18 or other means that are disposed symmetrically about theaxis XX′ of the implant. Such a spacer is either put into place insidethe cage 1 before the implant is put into place by being engaged thereinfrom the ends of the branches, or else the seat 7 has at least twocompatible grooves 19 allowing the said two splines 18 to slidetherealong when the spacer 2 is put into place if it needs to beinserted via the seat, the width e of the splines being no greater thanthe distance and the spacing between the distal ends of two adjacentbranches 5.

The device may include additional systems so that the branches do notdeform after they have been expanded, for example an outside ringreceived in a groove at the ends of the branches and deformable by thebranches.

In the embodiment shown in FIGS. 3, 4, and 5, the inside surfaces of thebranches 5 defining the inside volume 9 of the cage 1 are threaded witha pitch equivalent to that of the orifice 8 in the seat 7, e.g. as shownin FIG. 6, and said spacer 2 ₁ is threaded in compatible manner, asshown in FIGS. 13A and 13B.

In this embodiment with an inside thread, said cage 1 may also includeat least one other intermediate spacer 4 threaded like the end spacer 2₁ and capable of being screwed behind it in order firstly to compressthe bone matter that may have been inserted in the space defined betweenthe two spacers, and secondly to stiffen the central portion of thecage.

Said end and intermediate spacers 21 and 4 have respective polygonalaxial orifices 16 suitable for receiving a removable rod having a maleend of compatible shape so as to drive them while they are beinginstalled.

The frustoconical shape of the inside volume 9 of the cage 1 may have ahalf-angle of slope α lying in the range 6° to 9°, for example.

1. (canceled)
 2. A dynamic fusion device for facilitating arthrodesis ina disc space between adjacent vertebrae, comprising: a body extendingalong a longitudinal axis having a first portion and two or more legsdepending from said first portion, said first portion having a first endhaving a width of a first lateral distance, said legs laterally spacedapart from each other and defining a second end of said body spacedopposite from said first end, said second end having a width of a secondlateral distance, said legs defining an engaging member receivingcavity; and an engaging member secured to said body and received withinsaid engaging member receiving cavity, wherein said engaging member issecured to said body only by engagement of said engaging member withsaid legs.
 3. A dynamic fusion device for facilitating arthrodesis in adisc space between adjacent vertebrae as claimed in claim 2, whereinsaid engaging member slidably contacts said body whereby when saidengaging member is positioned at a first position the second lateraldistance approximately equals the first lateral distance and when theengaging member is positioned at a second position said engaging membercauses said legs to flex and the second lateral distance is differentthan the first lateral distance.
 4. A dynamic fusion device forfacilitating arthrodesis in a disc space between adjacent vertebrae asclaimed in claim 2, wherein when said engaging member is positioned atthe second position the second lateral distance is greater than thefirst lateral distance.
 5. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 3, wherein said engaging member positioned at the second positionis adjacent said second end.
 6. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, wherein said first portion is substantially cylindrical inshape.
 7. A dynamic fusion device for facilitating arthrodesis in a discspace between adjacent vertebrae as claimed in claim 6, wherein saidfirst portion is hollow.
 8. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, wherein said legs are spaced apart from each other defining apassageway through said body.
 9. A dynamic fusion device forfacilitating arthrodesis in a disc space between adjacent vertebrae asclaimed in claim 8, wherein said legs define a passageway extendingalong an axis transverse to the longitudinal axis.
 10. A dynamic fusiondevice for facilitating arthrodesis in a disc space between adjacentvertebrae as claimed in claim 2, wherein said first portion and saidlegs have curved outer surfaces, each of said outer surfaces having thesame radius of curvature.
 11. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, wherein said body has an outer surface having a radialprojection.
 12. A dynamic fusion device for facilitating arthrodesis ina disc space between adjacent vertebrae as claimed in claim 11, whereinsaid body outer surface comprises a plurality of radial projections inthe form of grooves.
 13. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 12, wherein said grooves are defined on more than half of thelength of said fusion device.
 14. A dynamic fusion device forfacilitating arthrodesis in a disc space between adjacent vertebrae asclaimed in claim 2, wherein said first portion includes an inner surfacethat defines a hollow cavity that is in communication with the engagingmember receiving cavity.
 15. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, further comprising an end cap, said first portion includes aninner surface defining a passageway having an open end, wherein said endcap attaches to said first end of said first portion and closes off theopen end of the passageway.
 16. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, wherein said body is made from a material capable ofwithstanding opposing forces between adjacent vertebrae and capable offlexing during expansion of the device.
 17. A dynamic fusion device forfacilitating arthrodesis in a disc space between adjacent vertebrae asclaimed in claim 2, wherein said first portion is substantiallycylindrical in shape and includes an inner surface that defines a hollowcavity that is in communication with the engaging member receivingcavity, said first leg and said second leg defining a passagewayextending along an axis transverse to the longitudinal axis for bonemass to grow therethrough.
 18. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 17, wherein said body has an outer surface that includes a radialprojection.
 19. A dynamic fusion device for facilitating arthrodesis ina disc space between adjacent vertebrae as claimed in claim 2, whereinsaid engaging member is secured to said second end of said body bymoving said engaging member from a position external of said body toengage with said second end of said body.
 20. A dynamic fusion devicefor facilitating arthrodesis in a disc space between adjacent vertebraeas claimed in claim 2, wherein at least one of said legs includes aninner surface that defines a ramp, whereby movement of said engagingmember along the longitudinal axis contacts said ramp causing said legto flex in a lateral direction and varying the second lateral distance.21. A dynamic fusion device for facilitating arthrodesis in a disc spacebetween adjacent vertebrae as claimed in claim 15, wherein said end capis made of a material which prevents bone matter from escaping from thedevice.
 22. A dynamic fusion device for facilitating arthrodesis in adisc space between adjacent vertebrae as claimed in claim 2, whereinsaid first portion defines one or more passageways for permitting bonemass to grow therethrough.
 23. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 2, where said engaging member includes a threaded passageway forthreadably receiving an adjustment rod for engaging said engaging memberwith said legs.
 24. A dynamic fusion device for facilitating arthrodesisin a disc space between adjacent vertebrae as claimed in claim 2,wherein said engaging member is a disc.
 25. A dynamic fusion device forfacilitating arthrodesis in a disc space between adjacent vertebrae asclaimed in claim 11, wherein said radial projection extends from atleast one of said legs.
 26. A dynamic fusion device for facilitatingarthrodesis in a disc space between adjacent vertebrae as claimed inclaim 12, wherein said grooves are defined on said legs.